Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation (NCT05398991) | Clinical Trial Compass
UnknownNot Applicable
Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation
China28 participantsStarted 2022-10-26
Plain-language summary
A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects aged ≥ 18 years.
. Subjects with perforated coronary or aortic-coronary bypass graft vessels.
. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
. The lesion is a perforated coronary artery or aortic coronary bypass graft vessel of Ellis type I, type II or type III.
. Reference vessel diameter from 2.5 mm to 4.0 mm.
. According to the judgment of the investigator, the perforations require covered stent coverage and for which the covered stent can be delivered.
. Up to one perforated lesion will be treated and up to one covered stent expected to be implanted.
Exclusion criteria
. Subjects who are unable to receive anticoagulation or antiplatelet therapy.
. Subjects who are unable to tolerate 6 months of DAPT treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Procedural Success
Timeframe: During hospitalization (up to 7 days after procedure)
. Subjects who are allergic to aspirin, heparin, contrast agents, cobalt-based alloys (including metallic elements such as cobalt, chromium, nickel, and tungsten), or polytetrafluoroethylene.
. According to the judgment of the investigator, subjects who are poorly compliant and unable to complete the study as required; or subjects who are otherwise deemed unsuitable for the enrollment.
. Primary or secondary cryptogenic coronary perforation or bleeding.
. Patients who are expected to require treatment with an adjunctive device such as IABP/ECMO.
. anatomical structures proximal to the target lesion or within the lesion (e.g., severe tortuosity, etc.) that would obstruct delivery of the coronary covered stent.
. implantation of the covered stent may result in occlusion of a significant coronary branch relevant to the treatment.